{"id":3237,"date":"2018-10-12T09:07:29","date_gmt":"2018-10-12T13:07:29","guid":{"rendered":"https:\/\/www.gensight-biologics.com\/gensight-biologics-presentera-des-resultats-de-letude-reverse-de-gs010-au-congres-annuel-2018-de-lamerican-academy-of-ophthalmology\/"},"modified":"2026-09-24T00:09:46","modified_gmt":"2026-09-24T04:09:46","slug":"gensight-biologics-presentera-des-resultats-de-letude-reverse-de-gs010-au-congres-annuel-2018-de-lamerican-academy-of-ophthalmology","status":"publish","type":"post","link":"https:\/\/www.gensight-biologics.com\/fr\/2018\/10\/12\/gensight-biologics-presentera-des-resultats-de-letude-reverse-de-gs010-au-congres-annuel-2018-de-lamerican-academy-of-ophthalmology\/","title":{"rendered":"GenSight Biologics pr\u00e9sentera des r\u00e9sultats de l\u2019\u00e9tude REVERSE de GS010 au Congr\u00e8s Annuel 2018 de l\u2019American Academy of Ophthalmology"},"content":{"rendered":"\nParis, France, le 12 octobre 2018, 7h30 CEST <\/strong>\u2013 GenSight Biologics (Euronext : SIGHT, ISIN : FR0013183985, \u00e9ligible PEA-PME), soci\u00e9t\u00e9 biopharmaceutique d\u00e9di\u00e9e \u00e0 la d\u00e9couverte et au d\u00e9veloppement de th\u00e9rapies g\u00e9niques innovantes pour le traitement des maladies neurod\u00e9g\u00e9n\u00e9ratives de la r\u00e9tine et du syst\u00e8me nerveux central, annonce aujourd\u2019hui\u00a0que les r\u00e9sultats \u00e0 48 semaines de l\u2019\u00e9tude clinique de Phase III REVERSE avec GS010 ont \u00e9t\u00e9 s\u00e9lectionn\u00e9s pour une pr\u00e9sentation orale au Congr\u00e8s Annuel 2018 de l\u2019American Academy of Ophthalmology<\/em> \u00e0 Chicago, IL, Etats-Unis, du 27 au 30 octobre 2018. Des membres de son \u00e9quipe de management pr\u00e9senteront \u00e9galement \u00e0 l\u2019Ophthalmology Innovation Summit<\/em> (OIS) le 25 octobre, en amont de la conf\u00e9rence.\n\n \n

Ophthalmology Innovation Summit (OIS) @AAO<\/strong><\/h3>\n25 octobre 2018 \u2013 Chicago (IL, Etats-Unis)<\/em><\/strong>\n\nDr. Barrett Katz, Chief Medical Officer, pr\u00e9sentera le 25 octobre au Marriott Marquis Hotel<\/em> \u00e0 Chicago, IL, Etats-Unis.\n\n \n

American Academy of Ophthalmology (AAO)<\/strong><\/h3>\n27-30 octobre 2018 \u2013 Chicago (IL, Etats-Unis)<\/em><\/strong>\n\n\u201cEfficacy of rAAV2\/2-ND4, an Investigational Gene Therapy for ND4 LHON: Top-line Results of Phase 3 Clinical Trial REVERSE\u201d<\/em> sera pr\u00e9sent\u00e9 par le Dr.<\/strong> Mark L. Moster<\/strong>, Neuro-Ophtalmologie, Wills Eye Hospital et Professeur de Neurologie et d\u2019Ophtalmologie \u00e0 la Thomas Jefferson University, Philadelphia, PA, Etats-Unis (investigateur dans les \u00e9tudes cliniques REVERSE et RESCUE).\n
    \n \t
  • Pr\u00e9sentation orale<\/em><\/li>\n \t
  • Session: Retina, Vitreous<\/em><\/li>\n \t
  • Num\u00e9ro d\u2019abstract: PA066<\/em><\/li>\n \t
  • Lundi 29 octobre 2018, 14h12 – 14h19 CDT<\/em><\/li>\n<\/ul>\n \n

    \u00c0 propos de GenSight\u00a0Biologics<\/strong><\/h3>\nGenSight Biologics S.A. (GenSight Biologics) est une soci\u00e9t\u00e9 biopharmaceutique d\u00e9di\u00e9e \u00e0 la d\u00e9couverte et au d\u00e9veloppement de th\u00e9rapies g\u00e9niques innovantes pour le traitement des maladies neurod\u00e9g\u00e9n\u00e9ratives de la r\u00e9tine et du syst\u00e8me nerveux central. Le portefeuille de recherche de GenSight Biologics s\u2019appuie sur deux plates-formes technologiques : le ciblage mitochondrial (Mitochondrial Targeting Sequence<\/em>, ou MTS) et l\u2019optog\u00e9n\u00e9tique, visant \u00e0 pr\u00e9server ou restaurer la vision chez les patients atteints de maladies neurod\u00e9g\u00e9n\u00e9ratives de la r\u00e9tine. Le candidat m\u00e9dicament le plus avanc\u00e9 de GenSight Biologics, GS010, est en Phase III pour le traitement de la neuropathie optique h\u00e9r\u00e9ditaire de Leber (NOHL), une maladie mitochondriale rare qui conduit \u00e0 une perte irr\u00e9versible de la vue chez les adolescents et les jeunes adultes. En utilisant son approche de th\u00e9rapie g\u00e9nique, les candidats m\u00e9dicaments de GenSight Biologics sont destin\u00e9s \u00e0 offrir aux patients une r\u00e9cup\u00e9ration visuelle fonctionnelle durable apr\u00e8s une seule injection intra-vitr\u00e9enne dans chaque \u0153il.\n

    \u00a0<\/strong>\u00c0 propos de GS010<\/strong><\/h3>\nGS010 cible la neuropathie optique h\u00e9r\u00e9ditaire de Leber (NOHL), et s\u2019appuie sur une technologie propri\u00e9taire de s\u00e9quence de ciblage mitochondrial (MTS), issue des travaux de l\u2019Institut de la Vision<\/em>, qui, lorsqu\u2019elle est associ\u00e9e au g\u00e8ne d\u2019int\u00e9r\u00eat, permet de l\u2019adresser sp\u00e9cifiquement \u00e0 l\u2019int\u00e9rieur de la mitochondrie gr\u00e2ce \u00e0 un vecteur AAV (Adeno-Associated Virus). Le g\u00e8ne d\u2019int\u00e9r\u00eat est ainsi transf\u00e9r\u00e9 dans la cellule pour y \u00eatre exprim\u00e9 et produire la prot\u00e9ine fonctionnelle, qui sera achemin\u00e9e \u00e0 l\u2019int\u00e9rieur des mitochondries gr\u00e2ce aux s\u00e9quences nucl\u00e9otidiques sp\u00e9cifiques, afin de restaurer la fonction mitochondriale d\u00e9ficiente ou manquante.\n

    \u00c0 propos de RESCUE et REVERSE<\/strong><\/h3>\nRESCUE et REVERSE sont deux \u00e9tudes distinctes pivotales de Phase III randomis\u00e9es, en double masqu\u00e9, contr\u00f4l\u00e9es par injection simul\u00e9e (sham), con\u00e7ues pour \u00e9valuer l\u2019efficacit\u00e9 d\u2019une injection intravitr\u00e9enne unique de GS010 (rAAV2\/2-ND4) chez des sujets atteints de la NOHL induite par la mutation G11778A ND4.\n\nLe crit\u00e8re d\u2019\u00e9valuation principal mesurera la diff\u00e9rence d\u2019efficacit\u00e9 de GS010 entre les yeux trait\u00e9s et les yeux non-trait\u00e9s (sham), sur la base de l\u2019acuit\u00e9 visuelle (Best Corrected Visual Acuity ou BCVA), mesur\u00e9e \u00e0 l\u2019aide de l\u2019\u00e9chelle ETDRS \u00e0 48 semaines apr\u00e8s injection. Les scores \u00ab Logarithm of the Minimal Angle of Resolution<\/em> \u00bb des patients, ou LogMAR, qui sont d\u00e9riv\u00e9s du nombre de lettres lues sur l\u2019\u00e9chelle ETDRS, seront utilis\u00e9s \u00e0 des fins statistiques. Les deux \u00e9tudes ont \u00e9t\u00e9 con\u00e7ues pour \u00e9valuer une diff\u00e9rence statistiquement significative d\u2019au moins 15 lettres ETDRS entre les yeux trait\u00e9s et non-trait\u00e9s (sham<\/em>), ajust\u00e9s de l\u2019acuit\u00e9 visuelle initiale (baseline<\/em>).\n\nLes crit\u00e8res d\u2019\u00e9valuation secondaires incluront l\u2019application de l\u2019analyse principale aux yeux ayant re\u00e7u GS010 et pr\u00e9sentant \u00e0 l\u2019inclusion la meilleure acuit\u00e9 visuelle initiale (\u00ab meilleur \u0153il \u00bb), compar\u00e9s \u00e0 ceux ayant re\u00e7u la proc\u00e9dure sham<\/em>, ainsi qu\u2019aux yeux ayant re\u00e7u GS010 et pr\u00e9sentant la moins bonne acuit\u00e9 visuelle initiale (\u00ab moins bon \u0153il \u00bb), compar\u00e9s \u00e0 ceux ayant re\u00e7u la proc\u00e9dure sham. Egalement, une \u00e9valuation de la proportion de patients \u00ab\u00a0r\u00e9pondeurs\u00a0\u00bb sera r\u00e9alis\u00e9e, incluant notamment le pourcentage de patients qui maintiennent leur acuit\u00e9 visuelle (perte de moins de 15 lettres ETDRS), le pourcentage de patients qui am\u00e9liorent leur acuit\u00e9 visuelle de 15 lettres ETDRS ou plus, ainsi que le pourcentage de patients pr\u00e9sentant une acuit\u00e9 visuelle finale >20\/200, ou 1\/10. Les param\u00e8tres visuels mesur\u00e9s incluront \u00e9galement les champs visuels automatis\u00e9s, la tomographie par coh\u00e9rence optique, ainsi que la sensibilit\u00e9 aux couleurs et aux contrastes, en plus des mesures de qualit\u00e9 de vie, de bio-diss\u00e9mination, et de r\u00e9ponse immunitaire post-injection.\n\nLes \u00e9tudes sont actuellement men\u00e9es en parall\u00e8le, chez 37 patients pour REVERSE et 39 patients pour RESCUE, dans 7 centres aux Etats-Unis, au Royaume-Uni, en France, en Allemagne et en Italie. Les premiers r\u00e9sultats \u00e0 48 semaines de suivi de RESCUE sont attendus au d\u00e9but du 1er<\/sup> trimestre 2019.\n\nIdentifiants ClinicalTrials.gov :<\/em>\n\nREVERSE: NCT02652780\n\nRESCUE: NCT02652767\n","protected":false},"excerpt":{"rendered":"

    Paris, France, le 12 octobre 2018, 7h30 CEST \u2013 GenSight Biologics (Euronext : SIGHT, ISIN : FR0013183985, \u00e9ligible PEA-PME), soci\u00e9t\u00e9 biopharmaceutique d\u00e9di\u00e9e \u00e0 la d\u00e9couverte et au d\u00e9veloppement de th\u00e9rapies g\u00e9niques innovantes pour le traitement des maladies neurod\u00e9g\u00e9n\u00e9ratives de la r\u00e9tine et du syst\u00e8me nerveux central, annonce aujourd\u2019hui\u00a0que les r\u00e9sultats \u00e0 48 semaines de l\u2019\u00e9tude […]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[54],"tags":[],"featured-area":[],"news-topic":[73],"news-type":[74,75,77],"post-year":[],"class_list":["post-3237","post","type-post","status-publish","format-standard","hentry","category-communiques-de-presse-financiers","news-topic-gs010-lumevoq","news-type-product-candidates","news-type-clinical","news-type-conferences"],"acf":[],"yoast_head":"\nGenSight Biologics pr\u00e9sentera des r\u00e9sultats de l\u2019\u00e9tude REVERSE de GS010 au Congr\u00e8s Annuel 2018 de l\u2019American Academy of Ophthalmology - 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